DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14, of record 7/17/2024, are pending and subject to prosecution.
Priority
The instant application is a national stage entry of PCT/EP2023/051493 (filed 1/23/2023). Acknowledgement is made of the applicant’s claim for foreign priority to EPO application 22153353.2 (filed 1/26/2022).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 5, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “the amino acids L-cysteine and L-tyrosine, and the vitamin biotin”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the salts: sodium chloride, magnesium sulphate, magnesium chloride·6H2O, calcium chloride·2H2O and potassium chloride”. There is insufficient antecedent basis for this limitation in the claim. Dependent claim 5 is included in the rejection.
Claim 14 recites the limitation “the proliferated cells”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 6, 9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (Fish & Shellfish Immunology, 1999), in view of Sigma Aldrich (Product data sheet, 2026 and webpage capture, 2021), Toullec (Methods in Cell Science, 1999), of record in IDS dated 7/17/2024, Cai et al. (Journal of Oceanography, 2014), and Le et al. (FR 2735146 A1, machine translation).
Regarding claims 1-2, 9, and 11-12: Watson et al. teach the culture of primary crab hyaline hemocytes (which read on “cells taken from a crustacean” and “hematopoietic tissue”) (See Abstract). The cells were maintained (which reads on “maintain viability”) in a medium comprising L15, MEM, or RPMI 1640 with penicillin and streptomycin (See page 183, full ¶3).
Sigma Aldrich teaches that RPMI 1640 comprises glycine, L-aspartic acid, L-asparagine, L-glutamic acid, hydroxy-L-proline (which reads on “L-proline”), L-serine, choline chloride, D-pantothenic acid hemicalcium salt (which reads on “calcium pantothenate”), folic acid, niacinamide (which reads on “nicotinamide”), pyridoxine hydrochloride (which reads on “pyridoxal hydrochloride”), riboflavin, thiamine hydrochloride, myo-inositol (which reads on “inositol”), glucose, L-cysteine, L-tyrosine, and biotin (See product data sheet).
Watson et al. teach the osmolality of the solutions as 925.8 ± 32.8 mOsm/kg, rather than the claimed 835 ± 55 mmol/kg. However, where claimed ranges do not overlap with the prior art but are merely close, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Watson et al. do not teach a medium pH of 7.2-7.4 or the inclusion of L-alanyl-L-glutamine, lactalbumin, and ultrafiltered crustacean hemolymph.
Sigma Aldrich teaches that the StableCell type of RPMI 1640 (R2405) uses L-alanyl-L-glutamine (which also reads on “L-alanine”) as a more stable form of glutamine for cell culture (See product data sheet and webpage capture).
Toullec reviews culture methods for primary crustacean cells (See Abstract). The pH of the culture medium is generally between 7.0-7.5 to approximate that of the native hemolymph (See page 193, col. 2, ¶1). Heat-inactivated crustacean hemolymph can be added for the purpose of enhancing cell proliferation (See page 195, col. 1, full ¶1).
Cai et al. review marine invertebrate cell culture and teach that lactalbumin enzyme hydrolysate (which reads on “lactalbumin”) can be added as a supplement to cultures of crustacean cells (See Abstract and page 408, col. 2, ¶1).
Le et al. teach methods for culturing marine invertebrate cells (See Abstract). Culture media are sterilized with a 0.2 µm filter (which reads on “ultrafiltered”) (See page 12, full ¶5).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the medium of Watson et al. to use RPMI 1640 with a more stable form of glutamine for culturing cells, as well as to comprise the addition of hemolymph and lactalbumin enzyme hydrolysate. One would have been motivated to incorporate hemolymph and lactalbumin enzyme hydrolysate because Toullec (See page 195, col. 1, full 1) and Cai et al. (See page 408, col. 2, ¶1) teach such additives as beneficial for crustacean cell culture. It also would have been obvious to adjust the medium pH to 7.0-7.5, as taught by Toullec for approximating the native environment of the cells (See page 193, col. 2, ¶1), and to sterilize the medium by filtration (the resulting medium would comprise “ultrafiltered crustacean hemolymph”), as taught by Le et al. With respect to the pH range, ranges that overlap or lie inside ranges disclosed by the prior art are considered to be prima facie obvious. See MPEP 2144.05(I). All of these modifications could be readily made to the medium of Watson et al.
Regarding claims 4 and 6: Following the discussion of claims 1-2, 9, and 11-12, Watson et al. teach that the hemocytes within culture flasks were gassed with 5% CO2-air mix (See page 184, full ¶1). Sigma Aldrich teaches that 1x RPMI 1640 comprises 2 g/l sodium bicarbonate (See product data sheet). The medium in the culture method of Watson et al. therefor reads on “pH is determined by the addition of sodium bicarbonate and the presence of CO2 in the air” and “pH is determined by the addition of the following concentrations of sodium bicarbonate and CO2: 2g/L sodium bicarbonate and the presence of 5% CO2 in the air”.
Regarding claim 13: Following the discussion of claims 1-2, 9, and 11-12, Watson et al. teach the culture of hyaline cells from crabs, rather than from shrimps or lobsters (See Abstract). However, Watson et al. state that the aim of their study was to develop a culture system for the hemocytes of marine decapod crustaceans (See page 182, full ¶2).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the culture medium of Watson et al., modified by Sigma Aldrich, Toullec, Cai et al., and Le et al., for culturing the hemocytes of other marine decapod crustaceans, such as shrimps and lobsters. One would have been motivated to make this modification because Watson et al. suggest that the medium would be suitable for culturing the hemocytes of marine decapod crustaceans, generally (See page 182, full ¶2), and such a modification could be readily performed.
Claims 1-4, 6, 9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (Fish & Shellfish Immunology, 1999), in view of Sigma Aldrich (Product data sheet, 2026 and webpage capture, 2021), Toullec (Methods in Cell Science, 1999), of record, Cai et al. (Journal of Oceanography, 2014), and Le et al. (FR 2735146 A1, machine translation), further in view of Sashikumar et al. (Cytotechnology, 2008) and Nguyen (Webpage capture, 2018).
The teachings of Watson et al., Sigma Aldrich, Toullec, Cai et al., and Le et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 3: Following the discussion of claims 1-2, 4, 6, 9, and 11-13, Watson et al., modified by Sigma Aldrich, Toullec, Cai et al., and Le et al., render obvious a medium for crustacean cell culture but do not teach the inclusion of the enumerated salts.
Sashikumar et al. teach the culture of primary crab cells (See Abstract). Medium prepared by reconstitution with artificial seawater increased the percentage of viable cells (See table 1). Addition of artificial seawater increased osmolarity (which reads on “osmolality is determined by the addition of the salts”) (See table 2).
Nguyen teaches a recipe for artificial seawater comprising sodium chloride, magnesium sulphate, magnesium chloride·6H2O, calcium chloride·2H2O, and potassium chloride (See webpage capture).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the medium of Watson et al., modified by Sigma Aldrich, Toullec, Cai et al., and Le et al., to reconstitute and/or supplement the RPMI 1640 with artificial seawater, such as with the recipe taught by Nguyen. One would have been motivated to make this modification because the results of Sashikumar et al. suggest that the addition of seawater to media for increasing osmolality can be beneficial for crustacean cell viability. There would be a reasonable expectation of success in doing so because artificial seawater could be readily used for reconstituting and/or supplementing media.
Claims 1-2, 4, 6, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (Fish & Shellfish Immunology, 1999), in view of Sigma Aldrich (Product data sheet, 2026 and webpage capture, 2021), Toullec (Methods in Cell Science, 1999), of record, Cai et al. (Journal of Oceanography, 2014), and Le et al. (FR 2735146 A1, machine translation), further in view of Thansa et al. (Cytotechnology, 2021).
The teachings of Watson et al., Sigma Aldrich, Toullec, Cai et al., and Le et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claim 10: Following the discussion of claims 1-2, 4, 6, 9, and 11-13, Watson et al., modified by Sigma Aldrich, Toullec, Cai et al., and Le et al., render obvious a medium for crustacean cell culture. Watson et al. teaches that 100 U/ml penicillin and 10 µg/ml streptomycin (corresponding to 100000 U/l penicillin and 100 mg/l streptomycin) were included in the medium (See page 183, full ¶3) but do not teach the inclusion of gentamicin and amphotericin B.
Thansa et al. teach the culture of hematopoietic cells from prawns (See Abstract). The culture medium comprised penicillin and streptomycin along with 50 µg/ml gentamicin and 250 µg/ml amphotericin B (which read on “50 mg/L gentamicin and 0.25 mg/L amphotericin B”) (See page 143, col. 1, ¶1).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the medium of Watson et al., modified by Sigma Aldrich, Toullec, Cai et al., and Le et al., to further comprise gentamicin and amphotericin B. One would have been motivated to make this modification because the use of gentamicin and amphotericin B by Thansa et al. in conjunction with penicillin and streptomycin suggests that such an antimicrobial mix is suitable for culturing crustacean hematopoietic cells, and the additional antimicrobial agents could be readily incorporated.
Allowable Subject Matter
Claims 7-8 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not appear to teach or suggest a cell culture medium with the claimed components at their claimed concentrations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/JENNIFER S SPENCE/Examiner, Art Unit 1633
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